Pfizer and its German partner on Tuesday said they submitted data concerning results of a COVID-19 vaccine trial in children as young as 5.
Pfizer and BioNTech sent the data to the U.S. Food and Drug Administration (FDA).
The data is from a Phase 2/3 trial examining the companies’ COVID-19 shot in children 5 to 11, an age group that cannot currently get a COVID-19 vaccine in the United States.
The companies say the data showed a favorable safety profile and that the vaccine triggered antibody responses in the children. The kids were given a two-dose regimen of 10 micrograms each.
The companies have not released full results from the trial. Results for children 6 months old to 4 years of age, another group being studied in the trial, are expected to be released in the fourth quarter of this year. The companies are planning to submit the trial data to a peer-reviewed publication at some point.
While the data was submitted to the FDA, Pfizer and BioNTech have not yet formally asked for emergency use authorization for the vaccine. The companies expect to send a formal submission “in the coming weeks,” with similar submissions planned for the European medical authority and other regulatory bodies, according to a press release.
Pfizer’s vaccine is the only one authorized for use in kids 12 to 15. It’s also approved for children ages 16 and 17.
The other two vaccines authorized in the United States are only cleared for adults 18 and older.
The FDA granted an expansion of the original emergency use authorization for children 12 to 15 about a month after Pfizer’s submission for that age group.
The companies are continuing to push for vaccinations for children despite kids being at low risk of contracting severe cases of COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. Federal health officials have also said they believe children should get vaccinated. They say kids can pass on the virus to people who are at high risk, including the elderly.
Dr. Janet Woodcock, acting head of the FDA, signaled earlier this month that the regulator will grant authorization for children. In a joint statement with Dr. Peter Marks, another FDA official, she said that officials are “eager to see COVID-19 vaccines available for young children.”
The FDA will analyze data on the shots for children and issue an emergency use authorization as appropriate after carefully analyzing the data to evaluate benefits and risks, the officials added.